Indications and uses
relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours
Calcium Polycarbophil
- Manufacturer
- SHANDONG XINHUA PHARMACEUTICAL CO., LTD.
- Effective date
- 2025-01-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- full-release
- Hydrated at
- 2026-06-01 00:51:40
Label at a glance#
ProductCalcium Polycarbophil
Active ingredientCALCIUM POLYCARBOPHIL
Label structure9 sections
Dosage and administration
take this product (child or adult dose) with a full glass of water (8oz.) or other fluid. Taking this product without enough liquid my cause choking. See choking warning. dosage will vary according to diet, exercise, previous laxative use or severity of constipation continued use for 1 to 3 days is normally required to provide full benefit adults and children over 12 years 2 caplets, 1 to 4 times per day childr...
Contacts and useful links#
Label contents#
Full prescribing information#
Drug Facts
Active ingredient (in each caplet)
Calcium polycarbophil 625 mg (equivalent to polycarbophil 500 mg)
Purpose
Bulk-forming laxative
Uses
relieves occasional constipation (irregularity)
generally produces bowel movement in 12 to 72 hours
WARNINGS SECTION
Choking: Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.
Ask a doctor before use if you have
abdominal pain, nausea, or vomiting
difficulty in swallowing
a sudden change in bowel habits that persists over a period of 2 weeks
Ask a doctor or pharmacist before use if you are
taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.
When using this product
do not use for more than 7 days unless directed by a doctor
do not take more than 8 caplets in a 24-hour period unless directed by a doctor
Stop use and ask a doctor if
you experience chest pain, abdominal pain, nausea, vomiting, difficulty in breathing or swallowing
you fail to have a bowel movement after use or have rectal bleeding. These could be signs of a serious condition.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
OVERDOSAGE SECTION
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
take this product (child or adult dose) with a full glass of water (8oz.) or other fluid. Taking this product without enough liquid my cause choking. See choking warning.
dosage will vary according to diet, exercise, previous laxative use or severity of constipation
continued use for 1 to 3 days is normally required to provide full benefit
| adults and children over 12 years | 2 caplets, 1 to 4 times per day |
| children under 12 years | ask a doctor |
Other information
each caplet contains: calcium 140 mg
do not use if printed seal under cap is torn or missing store in a dry place at 15° – 30°C (59° – 86°F)
protect contents from moisture
INACTIVE INGREDIENT SECTION
Caramel, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium lauryl sulfate
Questions or comments?
Call 1-844-374-0016 weekdays 9 AM to 5 PM EST
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Fiber Caplets
Compare to the active ingredient in FiberCon ®
BULK-FORMING / FIBER LAXATIVE
- GENTLE RELIEF OF CONSTIPATION
- WON’T CAUSE GAS OR BLOATING
- EFFECTIVE AS FIBER POWDERS
Distributed by: Xinhua Health Technology(HongKong)Co., Limited
Room 29 block a 13/f metropolitan fty & wh bldg 30-32chaiwan kok st tsuen wannt
90 Caplets
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58624-5003-1 | Calcium Polycarbophil | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 7 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58624-5003 | CALCIUM POLYCARBOPHIL TABLET, FILM COATED [SHANDONG XINHUA PHARMACEUTICAL CO., LTD.] | 7 | Current NDC, 1 package rows | 20250110_ee06868b-f741-8da2-e053-2a95a90a9772.zip |
Products#
Every source-derived product name is available through these pages.
- Calcium Polycarbophil
- CARAMEL
- SILICON DIOXIDE
- SODIUM LAURYL SULFATE
- CROSPOVIDONE
- MICROCRYSTALLINE CELLULOSE
- HYPROMELLOSES
- MAGNESIUM STEARATE
- POLYETHYLENE GLYCOL 400
- POLYCARBOPHIL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58624-5003 | 58624-5003-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CARAMEL | T9D99G2B1R | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| CROSPOVIDONE | 2S7830E561 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| CALCIUM POLYCARBOPHIL | 8F049NKY49 | ACTIB |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Calcium Polycarbophil | CALCIUM POLYCARBOPHIL | SHANDONG XINHUA PHARMACEUTICAL CO., LTD. | ee06868b-f741-8da2-e053-2a95a90a9772 | 2025-01-02 | Warnings | 58624-5003-1 58624-5003 58624500301 e7768a51-609b-4d3e-9864-b94ee9ccbdd9 ee06868b-f741-8da2-e053-2a95a90a9772 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.